Anchoring system for prosthetic and orthotic devices

ABSTRACT

An anchoring system for cable-activated prosthetic and orthotic devices is provided. Also provided is a prosthetic or orthotic system that includes the anchoring system, as well as methods for securing such a system to a wearer.

RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119(e) to U.S. patent application Ser. No. 60/793,178, filed on Apr. 19, 2006, the entire contents of which are hereby incorporated by reference.

TECHNICAL FIELD

This invention relates to prosthetic and orthotic devices.

BACKGROUND

Various limb prosthetic and orthotic devices require a harness system for their operation. However, the benefits of these devices are diminished by the harness system in that it can cause user discomfort, reduced cosmesis due to pulling on clothing, and in the case of upper limb prosthetic or orthotic devices, poor posturing of the shoulders, shoulder muscle asymmetry, and perceived pain in the contralateral shoulder, arm, and hand due, e.g., to impingement of axillae. Further, the function of a device with a harness system is often limited in that contralateral body power is needed to operate a terminal device affixed to the prosthetic or orthotic device.

SUMMARY

The present application provides a novel anchoring system that can replace the typical harness system used with cable-activated prosthetic and orthotic systems. Use of the anchoring system with a prosthetic or orthotic device can eliminate many of the problems associated with using a harness system.

Accordingly, in one aspect, the application provides an anchoring system. The anchoring system can include (i) a fastener comprising a base and a clasp-engaging member; and (ii) a clasp, comprising a first end configured to engage and rotate about the clasp-engaging member and a second end configured to engage an activation cable of a prosthetic or orthotic device.

In another aspect, the application provides a prosthetic or orthotic system. The system can include (a) an anchoring system that includes (i) a fastener comprising a base and a clasp-engaging member; and (ii) a clasp comprising a first end configured to engage and rotate about the clasp-engaging member and a second end engaged with an activation cable of a prosthetic or orthotic device; and (b) a prosthetic or orthotic device comprising an activation cable and a terminal device, wherein the activation cable comprises a first end operatively coupled to the terminal device and a second end engaged with the second end of the clasp.

The base and clasp engaging member can together be a unitary structure. Alternatively, the clasp engaging member can be detachably connected to the base. The clasp-engaging member can be flange, button, or knob that protrudes from a portion of the base, e.g., from about the center axis of the base.

The base can be a flat member that includes an adhesive side adapted to adhere the base to the body of a wearer, and a non-adhesive side. The base can be any shape, e.g., circular, rectangular, square, or triangular in shape. The size of the base can vary depending on the build and/or size of the wearer. For example, the base used by a child wearer may be rectangular in shape with a width of about 1-1.25 inches and a length of about 2 inches. As another example, the base used by an eighteen year old adult may be circular in shape with about a 3 inch diameter. The base can include a thermoplastic material, e.g., a perforated thermoplastic material. The fastener can also include a thermoplastic material. The clasp can be any shape, e.g., a loop or hook structure. The size of the clasp, e.g., the width of the clasp, can vary according to the size and/or build of the wearer. As an example, a 1 inch wide claps may work well for some wearers, while, e.g., a 1.5 inch wide clasp may be suitable for others.

The anchoring system can further include a linker between the clasp and the activation cable, and can be adjustable to accommodate different sizes of wearers, lengths of prosthetic or orthotic devices, and lengths of activation cables. The linker can include a cloth material, such as a canvas strap.

The prosthetic or orthotic system can include a prosthetic device, e.g., a prosthetic arm, such as a below elbow forearm prosthesis, or a prosthetic leg. The prosthetic device can include a prehensile terminal device, such as a prosthetic hand or hook. Alternatively, the prosthetic or orthotic system can include an orthotic device, e.g., a dynamic splint, such as a dynamic hand, forearm, elbow or leg splint.

In yet another aspect, the application provides a method of securing a prosthetic or orthotic device to a wearer. The method includes (a) attaching the prosthetic or orthotic device described herein to a limb of the wearer; (b) adhering the fastener to the upper back of the wearer; and (c) engaging the clasp and clasp-engaging member, thereby connecting the activation cable to the fastener and securing the prosthetic or orthotic device on the wearer. The fastener can be adhered to the back of the wearer, e.g., just medial to the scapula and in line with (or slightly above the level of) the axilla, e.g., without crossing the line of the vertebrae. Adhering the fastener so that it does not cross the line of the spine may be useful because, e.g., the contralateral side can be overdeveloped in a user from wearing a harness system. Placement of the device described herein without crossing the line of the spine would not require the wearer to continue using the contralateral side.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and equipment similar or equivalent to those described herein can be used in the practice of the present invention, suitable methods and equipment are described below. All publications and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features and advantages of the invention will be apparent from the description and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of a prosthetic device with an exemplary assembled anchoring system.

FIG. 2. is a perspective view of the prosthetic device depicted in FIG. 1 in a unassembled state.

FIGS. 3A-3G illustrate assembly of an exemplary fastener.

FIGS. 4A-4D illustrate the use of a “Figure of 8” harness system by a wearer of a prosthesis.

FIGS. 5A-5C illustrate the use of an exemplary anchoring system by a wearer of a prosthesis.

DETAILED DESCRIPTION

Provided herein is an anchoring system for cable-activated prosthetic and orthotic devices. The anchoring system enables the user to activate the cable-activated prosthetic or orthotic device's terminal device, e.g., by applying tension to the cable using scapulo-thoracic movement, without the aid of a harness system. This avoids problems associated with such harness systems.

Also provided is a prosthetic or orthotic system that includes the anchoring system, as well as methods for securing such a system to a wearer.

FIG. 1 provides an overview of an exemplary assembled prosthetic system 10 and an exemplary anchoring system 1A. The anchoring system includes, as its main components, a fastener 1B comprising a base 2, a clasp-engaging member 3, and a clasp 4. The system optionally includes a linker 5. In FIG. 1, linker 5 is connected to an activation cable 7 through a ball joint 6 between the two, such that the entire anchoring system is pivotably connected to a second end of activation cable 7. Activation cable 7 is connected at a first end to a terminal device 8, in this case a hook, mounted on a prosthetic device 9. In certain embodiments, clasp 4 can be configured to directly engage activation cable 7 of prosthetic or orthotic device 9, and linker 5 can be excluded.

FIG. 2 provides a slightly different perspective of the exemplary system depicted in FIG. 1 in an unassembled state. Clasp 4 is disengaged from clasp engaging member 3. Fastener 1B is not shown in FIG. 2.

Fastener 1B can be a unitary structure, i.e., clasp engaging member 3 and base 2 can be formed as a single unit, optionally including the same material, e.g., a thermoplastic material. Alternatively, base 2 and clasp engaging member 3 can be formed as separable units. In such embodiments, base 2 and clasp engaging member 3 can include the same or different materials.

Where base 2 and clasp-engaging member 3 are separable units, base 2 and clasp-engaging member 3 can be connected using any method known to those of skill in the art, e.g., riveting or bonding (e.g., gluing). Alternatively or in addition, base 2 can be constructed with a perforation configured such that it can receive clasp-engaging member 3 therethrough and hold clasp-engaging member 3 in position optionally with or without using other means. Base 2 can also be constructed with a perforation to accommodate embodiments wherein clasp-engaging member 3 is separable from base 2 and attached (reversibly or irreversibly) to clasp 4, and wherein the system is assembled by inserting clasp engaging member 3 into a perforation in base 2.

Base 2 can be constructed as a flat sheet of material, e.g., a patch. The flat sheet of material can be formed into any shape and size desirable to a skilled practitioner, including, inter alia, a circle, square, rectangle, triangle or octagon. The size of base 2 can vary depending on the build and/or size of the wearer. Base 2 can be a solid sheet of material or have one or more perforations, e.g., to enhance air flow through base 2 to the wearer's skin. Skilled practitioners will appreciate that it can be made of any material useful in such applications, e.g., a fabric, thermoplastic material, or metal, or a mixture thereof. For example, the base can be made of a perforated thermoplastic material, e.g., AQUAPLAST-T™.

Base 2 can include an adhesive on at least one side, which can be used to adhere fastener 1B to the skin of the wearer. The adhesive can be any adhesive known in the art, e.g., an adhesive acceptable for use on a wearer's skin. For example, the adhesive can be a medical glue or a tape (e.g., a double sided tape such as toupee tape).

Clasp-engaging member 3 can be any member that is suitable for use as a connection point between base 2 and clasp 4. In certain embodiments, clasp-engaging member 3 is a button (e.g., a so-called “bachelor button”), knob, or flange. Skilled practitioners will appreciate that clasp-engaging member can be made of any rigid material, e.g., a thermoplastic material or metal, e.g., steel, aluminum or titanium.

Clasp 4 is depicted in FIG. 1 and FIG. 2 as a typical clothing (e.g., “overalls”)-type clasp. However, skilled practitioners will appreciate that many variations on this theme are possible. For example, clasp 4 can be a simple hook or loop structure, configured at one end to connect with clasp-engaging member 3 and at the other end to connect with linker 5 or directly with activation cable 7, such that linker 5 can be excluded. Clasp 4 can be made of any material, e.g., a metal (e.g., steel or titanium) or thermoplastic material.

Linker 5 is optionally included in the system and can be any material, e.g., a cloth, such as canvass, metal, or thermoplastic material. Linker 5 can be adjustable in length, e.g., to accommodate, inter alia, different sizes of wearers, lengths of prosthetic or orthotic devices, etc.

Anchoring system 1A can be used with any cable-activated prosthesis or orthotic device. The prosthetic device 9 shown in FIG. 1 and FIG. 2 is a below elbow forearm prosthesis with a modified Muenster socket with a terminal hook. However, skilled practitioners will appreciate that many other cable-activated prosthetic and orthotic devices for upper and lower limbs are known and commercially available, as are other terminal devices. For example, anchoring system 1A can be used with a prosthesis that replaces the entire arm and/or that include a prosthetic hand or other prehensile device. As another example, with regard to orthotic devices, anchoring system 1A can be used with a dynamic splint, e.g., a dynamic hand, forearm, or elbow splint. The system can also be used with lower limb prostheses and orthotic devices. For example, the system can be used with a cable-activated prosthetic leg or a dynamic leg (e.g., knee) splint.

There are various ways of adhering base 2 and/or fastener 1B of the system described herein to the skin of the wearer. For example, before the wearer adheres base 2 or fastener 1B to the skin, he or she can wipe the base and/or the skin with alcohol and let it dry. Base 2 can adhere better to dry skin. Additionally, cleaning base 2 and/or the skin with alcohol can maintain the skin and the device clean and hygienic. Alternatively or in addition, the wearer can treat the skin with benzoin. Alternatively or in addition, the wearer can spray the area of the skin to which base 2 will be adhered with an athletic spray (e.g., Tuf Skin) that can make the area more “sticky” or “tacky.” After one or few days of wear, base 2 and/or fastener 1B can begin to pull away from the skin, e.g., after the wearer takes a shower. To maintain base 2 on the skin, after, e.g., a shower, the wearer can dry base 2 with a hairdryer, which can reactivate, e.g., the adhesive of the tape with which base 2 was adhered to the skin. Various methods of adhering base 2 to the skin described herein can extend the time for which base 2 can remain on the skin of the wearer. For example, base 2 can remain on the wearer for e.g., three or four consecutive days. Removal of base 2 and/or fastener 1B from the skin can be done by gently pulling it away from the skin. Alternatively or in addition, taking a bubble or an oily bath can facilitate removal of base 2 from the skin.

The system is suitable for use with any population, child or adult, having a condition (congenital or acquired) that benefits from the use of a cable-activated prosthetic or orthotic device. For example, it can be used in those having a below elbow upper limb deficiency, spinal cord injury, brachial plexus palsy, cerebral palsy with hemiplegia, head trauma, or hand trauma, among many others.

The invention will be further described in the following examples, which do not limit the scope of the invention defined by the claims.

EXAMPLE 1 Construction of an Exemplary Fastener and Use Thereof

FIGS. 3A-3G illustrate the assembly of an exemplary fastener. Assembly in this instance requires a perforated thermoplastic material, such as AQUAPLAST-T™, a bachelor button (e.g., a DRITZ® bachelor button) fastened through and held approximately in the center by the perforated thermoplastic material (see FIG. 3A). A double sided tape, such as toupee tape, was cut to roughly the size of the perforated thermoplastic material (see FIGS. 3B-3D). The double sided tape was trimmed from the perforated thermoplastic material (see FIG. 3E). The backing was then removed from the double sided tape to yield a fastener prepared for use (see FIGS. 3F-3G).

FIGS. 4A-4D are presented for the purposes of contrasting the embodiment demonstrated in the present Example with prior art systems. These figures illustrate the use of a prior art system—a so-called “Figure of 8” harness system. FIG. 4A is a side view of a wearer of the harness system. FIG. 4B is a back view of a wearer of the harness system. FIG. 4C is a frontal view of a wearer of the harness system, with arm and prosthesis extended above the head. Note how one of the harness straps inconveniently lifts off of and above the right shoulder of the wearer. FIG. 4D is a side view of the wearer with arm extended and prehensile hook in open position.

FIGS. 5A-5C illustrate the use of an exemplary anchoring system prepared in part in a procedure similar to that outlined above in FIGS. 3A-3G. Specifically, FIGS. 5A-5C illustrate assembly of a prosthetic system of the present invention on a wearer. FIGS. 5A-5C are side views of a wearer with a elbow forearm prosthesis with a modified Muenster socket and a prehensile hook. The fastener was affixed to the wearer's skin just medial to the scapula and slightly above the level of the axilla (see FIG. 5A). The wearer, with his/her opposite hand, grasped the clasp and/or linker attached to the activation cable and engaged (e.g., hooked) the clasp with the clasp-engaging member (FIG. 5B). Upon engagement, the device was fully assembled and activated (FIG. 5C).

A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims. 

1. An anchoring system comprising: (i) a fastener comprising a base and a clasp-engaging member; and (ii) a clasp, comprising a first end configured to engage and rotate about the clasp-engaging member and a second end configured to engage an activation cable of a prosthetic or orthotic device.
 2. A prosthetic or orthotic system, comprising: (a) the anchoring system of claim 1; and (b) a prosthetic or orthotic device comprising an activation cable and a terminal device, wherein the activation cable comprises a first end operatively coupled to the terminal device and a second end engaged with the second end of the clasp.
 3. The system of claim 1, wherein the base and clasp engaging member are together a unitary structure.
 4. The system of claim 1, wherein the clasp engaging member is detachably connected to the base.
 5. The system of claim 1, wherein the clasp-engaging member is a flange that protrudes from a portion of the base.
 6. The system of claim 1, wherein the clasp-engaging member is a button.
 7. The system of claim 1, wherein the base is a flat member comprising an adhesive side adapted to adhere the base to the body of a wearer and a non-adhesive side.
 8. The system of claim 7, wherein the base is circular, rectangular, square, or triangular in shape.
 9. The system of claim 1, wherein the base comprises a thermoplastic material.
 10. The system of claim 1, wherein the base comprises a perforated thermoplastic material.
 11. The system of claim 1, wherein the fastener comprises a thermoplastic material.
 12. The system of claim 1, wherein the clasp at the first end comprises a loop or a hook.
 13. The system of claim 2, wherein the anchoring system further comprises a linker between the clasp and the activation cable.
 14. The system of claim 13, wherein the linker comprises a cloth material.
 15. The system of claim 13, wherein the linker is a canvas strap.
 16. The system of claim 2, wherein the system comprises a prosthetic device.
 17. The system of claim 16, wherein the prosthetic device is a prosthetic arm.
 18. The system of claim 17, wherein the prosthetic device is a below elbow forearm prosthesis.
 19. The system of claim 17, wherein the prosthetic device is a prosthetic leg.
 20. The system of claim 16, wherein the terminal device is a prehensile device.
 21. The system of claim 20, wherein the prehensile device is a prosthetic hand or a hook.
 22. The system of claim 2, wherein the device comprises an orthotic device.
 23. The system of claim 22, wherein the orthotic device is a dynamic splint.
 24. The system of claim 23, wherein the dynamic splint is selected from the group consisting of: a dynamic leg splint, a dynamic hand splint, a dynamic forearm splint, and a dynamic elbow splint.
 25. A method of securing a prosthetic or orthotic device to a wearer, comprising: (a) attaching the prosthetic or orthotic device of claim 2 to a limb of the wearer; (b) adhering the fastener to the upper back of the wearer; and (c) engaging the clasp and clasp-engaging member, thereby connecting the activation cable to the fastener and securing the prosthetic or orthotic device on the wearer. 